| CTRI Number |
CTRI/2021/03/032041 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Block of nerve group around Hip capsule versus Block in Iliac Fascia above Inguinal liagament in patients undergoing Total Hip Replacement |
|
Scientific Title of Study
|
Comparing the efficacy of Pericapsular nerve group block (PENG) block versus Supra-inguinal fascia iliaca block (FIB) in Total Hip Arthroplasty : A prospective randomized control trial. |
| Trial Acronym |
PENG vs FIB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 572657332016 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chethan V |
| Designation |
JR IN MD ANAESTHESIOLOGY |
| Affiliation |
ALL INDIAN INSTITUTE OF MEDICAL SCIENCES PATNA. |
| Address |
ROOM NO 308 AIIMS PATNA PG BOYS HOSTEL 10 AIIMS CAMPUS PULWARISHARIF PATNA. DEPARTMENT OF ANAESTHESIOLOGY
AIIMS PATNA Patna BIHAR 801507 India |
| Phone |
9972491570 |
| Fax |
|
| Email |
chethanvamshi20@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Chethan V |
| Designation |
JR IN MD ANAESTHESIOLOGY |
| Affiliation |
ALL INDIAN INSTITUTE OF MEDICAL SCIENCES PATNA. |
| Address |
ROOM NO 308 AIIMS PATNA PG BOYS HOSTEL 10 AIIMS CAMPUS PULWARISHARIF PATNA. DEPARTMENT OF ANAESTHESIOLOGY
AIIMS PATNA Patna BIHAR 801507 India |
| Phone |
9972491570 |
| Fax |
|
| Email |
chethanvamshi20@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Chethan V |
| Designation |
JR IN MD ANAESTHESIOLOGY |
| Affiliation |
ALL INDIAN INSTITUTE OF MEDICAL SCIENCES PATNA. |
| Address |
ROOM NO 308 AIIMS PATNA PG BOYS HOSTEL 10 AIIMS CAMPUS PULWARISHARIF PATNA. DEPARTMENT OF ANAESTHESIOLOGY
AIIMS PATNA Patna BIHAR 801507 India |
| Phone |
9972491570 |
| Fax |
|
| Email |
chethanvamshi20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not funded |
| Address |
N/A |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ajeet Kumar |
AIIMS Patna |
Operation Theatre, Department of Anaesthesiology AIIMS Patna Patna BIHAR |
9312501413
ajeetanaes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PENG(Pericapsular nerve group ) |
under all aseptic precautions A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution 30ml of bupivacaine 0.25% +1mcg/kg clonidine will be injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL.
Group S patients will receive the USG guided Suprainguinal FIB. After all aseptic preparation a high frequency linear USG probe will be place transversely below the femoral crease and femoral artery will be delineated. Then, the probe will be moved laterally and a echo-lucent dark illio-psoas muscle will be seen lateral to the femoral artery which is covered by a hyper echoic white line like structure called fascia iliaca. Then, the probe will be rotated in para-sagittal plane at the same place and the iliacus muscle and its covering fascia iliaca are identified in the pelvis below the abdominal muscles. After this the needle is introduced from the 1-2 cm below the inguinal ligament in –plane to the probe directed towards the pelvis and 30ml solution containing 0.25% bupivacaine+ 1mcg/kg clonidine will be injected below the fascia liaca after a negative aspiration test. |
| Comparator Agent |
SIB(suprainguinal fascia iliaca block) |
Group S patients will receive the USG guided Suprainguinal FIB. After all aseptic preparation a high frequency linear USG probe will be place transversely below the femoral crease and femoral artery will be delineated. Then, the probe will be moved laterally and a echo-lucent dark illio-psoas muscle will be seen lateral to the femoral artery which is covered by a hyper echoic white line like structure called fascia iliaca. Then, the probe will be rotated in para-sagittal plane at the same place and the iliacus muscle and its covering fascia iliaca are identified in the pelvis below the abdominal muscles. After this the needle is introduced from the 1-2 cm below the inguinal ligament in –plane to the probe directed towards the pelvis and 30ml solution containing 0.25% bupivacaine+ 1mcg/kg clonidine will be injected below the fascia liaca after a negative aspiration test. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective Total Hip arthroplasty.
2. ASA I and II including both the sexes.
3. Age group: 25 to 75 years. |
|
| ExclusionCriteria |
| Details |
1. ASA III / IV
​ 2. Patient refusal to take part in the study
3. Morbid obesity (BMI ≥ 40)
4.History of focal neurological deficit
5.History of sensory or motor disorders of limb to be operated
6. History of allergy to local anaesthetics, clonidine
7. History of regular opioid use
8. Infection at puncture site for both approaches of block
. ​ 9. Inability to comprehend NRS pain assessment scale
10. Inability to understand the use of PCA device |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 24-hour morphine consumption. |
24-hour morphine consumption. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative opioid consumption
•Mean Numerical rating scale[NRS]in 24 hours
•Worst NRS in 24 hours
•Weakness of Quadriceps femoris muscle
•Quality of Recovery.
•Time to first activation of PCA pump.
•Complications of block.
•Assessment of Quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patients knee will be fully flexed, and the patient will be asked to extend it. |
48 hrs |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current modalities for pain control often rely on multimodal analgesia. Opioids remain an integral part of most analgesic plans either via intravenous boluses, infusion or patient controlled analgesia (PCA) pumps. Using opioids alone intensifies their side-effect profile that includes, postoperative nausea and vomiting (PONV), sedation, pruritus and respiratory depression.The common opioid sparing methods are use of non-steroidal anti inflammatory drugs (NSAIDs), spinal opioids, epidural postoperative analgesia and peripheral nerve blockade3.Peripheral nerve blockade has started gaining attention in the recent past for arthroplasty. Although its place is well recognized in knee arthroplasty its place in hip arthroplasty is not well defined. The modified supra inguinal approach of FIB described by Stevens places the local anaesthetic (LA) solution in the fascia iliaca plane higher up than the conventional technique and thus allow more superior spread of (LAs) and hence blockade of nerves derived from L1 and L2 anterior rami of lumbar plexus (ilioinguinal, iliohypogastric and genitofemoral) leading to more effective pain relif. 5We The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported. The hypothesis of this study is that a PENG block will provide a better postoperative analgesia and reduce opioid consumption in the postoperative period in patients undergoing THR. |